Many dental laboratory owners will remember the changes to the Medical Devices Directive that came into force in March 2010 which included changes such as the patient statement and a legal requirement to record complaints. But were you aware that as part of these changes the registration details of manufacturers including dental laboratories changed from being confidential to that of a public register.

Prior to 2010 all manufacturers that were registered with the MHRA were written to and informed that information held by the MHRA would no longer be confidential and as part of the process of releasing this information on a public register manufacturers had to confirm their registration details.

The letter sent out by the MHRA required that all dental laboratories confirm their registration information was correct and that continued registration was required by the laboratory. This confirmation by the dental laboratory was required in writing. Essentially if no confirmation was received from the dental laboratory manufacturer by the MHRA prior to the deadline in 2009 then the MHRA archived the laboratory registration and considered the laboratory to be no longer registered.

If you had moved business premises since your first registration with the MHRA which was previously named the Medical Devices Agency (MDA) and you didn’t inform the MHRA you would not have received this letter and you may not now be registered.

It is essential that all manufacturers verify their registration to ensure that the dental laboratory is registered and that the registration details are correct and up to date.

To check if your dental laboratory registration is current visit the following link which will take you directly to the register for dental appliances, alternatively you may visit the MHRA website and undertake a general search using the following wording ‘Access to the Medical Devices Register’:

http://aic.mhra.gov.uk/era/pdr.nsf/devicecode?openpage&RestrictToCategory=K1&start=1&count=200

If your dental laboratory information is incorrect or out of date then you will need to rectify this by accessing the MHRA’s Devices Online Registration System (DORS). This online registration system can be accessed at https://aic.mhra.gov.uk/era/drsystem.nsf/login . Once your account is activated by the MHRA you will be able to make the necessary changes. Please note that for new and subsequent changes to the registered details held by the MHRA, the statutory fee of £70.00 will be charged.

If you need help with any aspect of MHRA registration contact the DLA office on 0115 9254888

The prospect of having your systems inspected can be quite daunting so to try and allay your fears below is a brief overview of what you can expect to happen on your DAMAS inspection day.

Most laboratories are choosing to purchase an off the shelf system from the DLA which guides you through the implementation stages. It is very important that your laboratory procedures comply with each clause of the DAMAS Specification and it is important to remember that simply buying the ‘DAMAS Implementation System’ from the DLA is not enough to prove compliance.

Once you have implemented all of the procedures to comply with DAMAS you need to check that it actually satisfies the requirements. This check is called internal auditing. What you may find by undertaking this internal audit is that not everything is being done correctly – this is called a nonconformity. Don’t worry about getting nonconformities just fix them and make sure they don’t happen again. Once you have one internal audit under your belt, you should carry out a management review which should determine if your system has been compromised by the number of nonconformities found.

When you are satisfied that your system meets the requirements of DAMAS, and you have a minimum of three months records, you may then apply to have your audit.

On the day of the assessment, the assessor will explain what will happen during the day. They will then assess your system for conformity with the DAMAS requirements. This will be done by examining samples of your records and assessing if these are sufficient to demonstrate conformity. The assessor will need a tour of your laboratory to look how your processes are undertaken which will include amongst other things, booking in, booking out and final inspection.

The assessor will take lots of notes and ask different questions about all different aspects of your manufacturing processes. Don’t worry about this. The assessor has to make records of their assessment so that random checks may be made to ensure that assessors are doing the job correctly!

When the assessor has finished, they will confirm any nonconformities they have found. It is up to you to fix nonconformities. In some instances, the assessor will guide you in the right direction but there are limitations on what guidance they can give. In all circumstances the assessor will let you know how to complete any paperwork which puts right any nonconformities that are identified.

In most cases, the assessor will find nonconformities of a minor nature that can be quickly fixed and that are not a cause for concern. The assessor will advise you that, in their opinion, your system meets the DAMAS requirements and that they will be recommending your registration as a DAMAS laboratory.

The DLA will confirm your DAMAS registration in writing and provide a copy of the DAMAS logo which may be used to promote your DAMAS status and on your lab stationery and lab tickets. It is also worthwhile writing to your clients to tell them about your success and that you now have independent proof that you are complying with the law, namely the Medical Devices Regulations and Medical Devices Directive. This is principally what DAMAS is about!

DAMAS registrations continue to increases across the UK, with the number of DAMAS registered laboratories reaching an all-time high of 420.

So what does this equate to nationally?

Size of DAMAS Laboratories:

For more information on DAMAS including how to become DAMAS registered contact the DLA office on 0115 9254888.

For many years, GDC registrants have been required to have appropriate indemnity arrangements in place so that patients can claim any compensation to which they may be entitled. This requirement is part of the GDC Standards.

However, since July 2014, all registered healthcare professionals are legally required to have indemnity cover.

The GDC changed the registration rules so that dentists and dental care professionals applying for registration or restoration, and those renewing their registration each year, will be required to tell the GDC that they have indemnity cover in place – or will have by the time they start practising.

The idea behind the change is that you won’t be able to register or renew your registration unless you can confirm to us that you have, or will have, cover in place. This will reduce the number of people working without cover.

It’s important to note that the requirement to ​have appropriate indemnity cover is not new and has not changed. The main difference that current registrants will notice is that when you renew your registration through eGDC each year, you will have to confirm that you have indemnity cover in place, or will have when you start to practise. If you don’t confirm this, you will not be able to renew your registration.

Some people may be asked to provide details of their policy to the GDC when they are applying for registration, applying for restoration, or when renewing their registration during the ARF period. Each individual applicant or registrant will need to know the details of their indemnity cover, and to provide details of these to the GDC if asked to do so.

If you do not have your own indemnity cover, for example you are covered under your employer’s policy, you will need to make sure you have, or can access, the details of the policy if the GDC ask you to provide them. If you are a dental laboratory owner with DCPs covered under your policy, you will need to make the appropriate information available to them should they need it.

The first group of dental professionals to have to make this declaration will be DCPs during the ARF collection period in summer 2016.

For further information or to access frequently asked questions regarding indemnity insurance, you can visit the GDC website at:

http://www.gdc-uk.org/dentalprofessionals/standards/pages/indemnity.aspx

What is DAMAS?

The Dental Appliance Manufacturers Audit Scheme (DAMAS) is a quality assurance management system, similar to systems such as ISO 9001, but has been simplified and tailored specifically towards the dental industry. It provides the opportunity for laboratories to become certified as a laboratory that is in compliance with the law.

There are many benefits to being able to call yourself a DAMAS laboratory:

Retaining clients:

As more and more clients, (particularly bigger corporate clients) look for a straightforward way to select their labs, some are now specifying that they will only use labs with such proven registrations (DAMAS).

The potential to attract new clients:

As the number of DAMAS laboratories continues to grow, when seeking out new laboratories to try, clients will know at a glance that you have proven your labs compliance to the law and a commitment to quality.

Promotion for your laboratory:

Once registered your laboratory will be published on the DAMAS website, making it easier for people to find you.

Peace of mind:

Knowing that your laboratory is in conformity with the requirements of the MDD and MDR, for you and your clients.

A simple to follow management system:

A simple system to help ensure the smooth day-to-day running of your business.

CPD:

After having implemented the system and passed your first external       audit, you and your staff will be eligible to receive verifiable CPD.

Becoming DAMAS Registered:

There are a few routes that you can take to start the process:

Using the DAMAS Specification as a guide implement your own system.

Buy in the DLA DAMAS Implementation System and follow the guidance provided to implement the system.

If you have already bought the DAMAS folders from the DLA, but feel you do not have the time to implement the system yourself or would like more support, a DAMAS Consultant can come into your laboratory and implement your system for you.

For more information on any areas about becoming DAMAS registered or for more details on the amount of CPD you could claim as a DAMAS laboratory please feel free to contact the DAMAS office, via the DLA on 0115 925 4888 or email to info@damas.co.uk

If you are already a registered DAMAS laboratory, you will know that as part of the system you need to conduct Internal Audits.

The frequency of the Internal Audits is up to you, they need to be conducted, as a minimum, annually, a little before your External Audit is due. Some laboratories choose to undertake Internal Audits quite frequently, and certainly for bigger laboratories, this can make it easier to keep on top of the system.

The purpose of the Internal Audit:

Conducting the Internal Audit gives the laboratory an accurate view and understanding of whether the DAMAS Compliance System is running effectively within the lab, and if it isn’t, why this is.

Once you have been through the Internal Audit process and recorded the findings on the internal audit format, the next thing to do is to undertake a Management Review.

The Purpose of the Management Review:

The Management Review is usually, conducted by more than one individual and follows on from the Internal Audit. The purpose is to assess the findings that arose during the Audit, and to see if any corrective action is required. If there are any issues uncovered, then a corrective action plan(s) can be formulated using this form.